Clinical Strategy Consultant

Location: United States

Job Description:

Career Opportunities: Clinical Strategy Consultant (5515)

Requisition ID 5515 -  Work From Home - United States

Job Description Print Preview

 

Work Location - Remote

JobSummary

This role serves as the company's clinical & medical expert for client projects. Advise on clinical development (FIH to PoC), study design, and medical monitoring. Ensure nonclinical programs support clinical entry. Represent clients in CRO negotiations, and bridge clinical needs with internal development and manufacturing.

Job Responsibilities

1. Clinica Advisory

Advise on Phase I/II trial design (dose escalation, endpoints, I/E criteria) for large molecules (mAbs, ADCs, bispecifics, fusion proteins). Guide medical monitoring (SAE review, dose rules). Translate clinical supply needs (batch size, stability) into internal manufacturing considerations. Ensure nonclinical programs (GLP toxicology, species, starting dose like MABEL/NOAEL) enable clinical entry; review data to identify risks (e.g., cytokine release) and mitigation strategies.

2. CRO Negotiation (Client Representation)

Lead scope, budget, and contract negotiations with clinical/nonclinical CROs on behalf of clients. Evaluate proposals, protocols, and ICFs. Provide oversight - attend investigator meetings, review clinical data, interpret safety/efficacy results, ensure CRO deliverables meet expectations.

3. Internal Bridge (Manufacturing → Clinical Trials)

Work with internal CMC teams to ensure clinical batch production meets study needs (dose strength, blinding, stability). Advise on comparability strategies when manufacturing changes.

4. BD, Client Engagement & Knowledge

Support client presentations and bid defenses; identify clinical red flags in early-stage projects. Track trial design trends (adaptive, biomarker-driven). Maintain regulatory awareness (FDA, EMA, NMPA) on endpoints and safety reporting.

Qualifications

Education & Experience

• MD (board certification in oncology/rheumatology/neurology/immunology strongly preferred).
• 5-8 years in biopharma/clinical research, with ≥3 years direct clinical development (medical monitor, clinical scientist, or CRO advisor), preferably in leading Phase 1 trials in China and/or Australia.
• Proven CRO negotiation experience (sponsor/client side). Prior CRO/CDMO/clinical consulting highly desirable.
• Deep understanding of large-molecule clinical & nonclinical development (immunogenicity, PK/PD).

Core Skills:

• Hands-on: Phase I/II design, protocol writing, medical monitoring, safety data review (SAE/SUSAR). Experience of leading Phase 1 trials in China and/or Australia is a big plus.
• Interpret clinical data & nonclinical toxicology reports; translate to manufacturing.
• Strong negotiation & vendor management; excellent client communication (trusted partner); fluent English.
• Preferred: Regulatory interactions (pre-IND, EOP2); clinical supply logistics (labeling, cold chain, distribution).

The job description does not intend to list all the duties and responsibilities assigned to this position. Employee holding this position would be required to perform other job-related duties/responsibilities based on their expertise and company business needs.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

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Job Title - Clinical Strategy Consultant

Work Location - Remote

JobSummary

This role serves as the company's clinical & medical expert for client projects. Advise on clinical development (FIH to PoC), study design, and medical monitoring. Ensure nonclinical programs support clinical entry. Represent clients in CRO negotiations, and bridge clinical needs with internal development and manufacturing.

Job Responsibilities

1. Clinica Advisory

Advise on Phase I/II trial design (dose escalation, endpoints, I/E criteria) for large molecules (mAbs, ADCs, bispecifics, fusion proteins). Guide medical monitoring (SAE review, dose rules). Translate clinical supply needs (batch size, stability) into internal manufacturing considerations. Ensure nonclinical programs (GLP toxicology, species, starting dose like MABEL/NOAEL) enable clinical entry; review data to identify risks (e.g., cytokine release) and mitigation strategies.

2. CRO Negotiation (Client Representation)

Lead scope, budget, and contract negotiations with clinical/nonclinical CROs on behalf of clients. Evaluate proposals, protocols, and ICFs. Provide oversight - attend investigator meetings, review clinical data, interpret safety/efficacy results, ensure CRO deliverables meet expectations.

3. Internal Bridge (Manufacturing → Clinical Trials)

Work with internal CMC teams to ensure clinical batch production meets study needs (dose strength, blinding, stability). Advise on comparability strategies when manufacturing changes.

4. BD, Client Engagement & Knowledge

Support client presentations and bid defenses; identify clinical red flags in early-stage projects. Track trial design trends (adaptive, biomarker-driven). Maintain regulatory awareness (FDA, EMA, NMPA) on endpoints and safety reporting.

Qualifications

Education & Experience

• MD (board certification in oncology/rheumatology/neurology/immunology strongly preferred).
• 5-8 years in biopharma/clinical research, with ≥3 years direct clinical development (medical monitor, clinical scientist, or CRO advisor), preferably in leading Phase 1 trials in China and/or Australia.
• Proven CRO negotiation experience (sponsor/client side). Prior CRO/CDMO/clinical consulting highly desirable.
• Deep understanding of large-molecule clinical & nonclinical development (immunogenicity, PK/PD).

Core Skills:

• Hands-on: Phase I/II design, protocol writing, medical monitoring, safety data review (SAE/SUSAR). Experience of leading Phase 1 trials in China and/or Australia is a big plus.
• Interpret clinical data & nonclinical toxicology reports; translate to manufacturing.
• Strong negotiation & vendor management; excellent client communication (trusted partner); fluent English.
• Preferred: Regulatory interactions (pre-IND, EOP2); clinical supply logistics (labeling, cold chain, distribution).

The job description does not intend to list all the duties and responsibilities assigned to this position. Employee holding this position would be required to perform other job-related duties/responsibilities based on their expertise and company business needs.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability